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Author: Susan Onel Publisher: ISBN: 9781402427749 Category : Medical instruments and apparatus Languages : en Pages : 1112
Book Description
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Author: Susan Onel Publisher: ISBN: 9781402427749 Category : Medical instruments and apparatus Languages : en Pages : 1112
Book Description
This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Author: Belinda Bennett Publisher: Oxford University Press ISBN: 0192896741 Category : Law Languages : en Pages : 721
Book Description
COVID-19 is the most severe pandemic the world has experienced in a century. This book analyses major legal and regulatory responses internationally to COVID-19, and the impact the pandemic has had on human rights and freedoms, governance, the obligations of states and individuals, as well the role of the World Health Organization and other international bodies during this time. The authors examine notable legal challenges to public health measures enforced during the pandemic, such as lockdown orders, curfews, and vaccine mandates. Importantly, the book contextualizes the legal analysis by examining the broader social and economic dimensions of risks posed by the pandemic. The book considers how COVID-19 impacted the operation of the criminal justice system, civil litigation concerning negligently caused deaths and business losses arising from contractual breaches, consumer protection litigation, disciplinary regulation of health practitioners, coronial inquests and other investigations of unexpected deaths, and occupational health and safety issues. The book reflects on the role of the law in facilitating the remarkable scientific and epidemiological achievements during the pandemic, but also the challenges of ensuring the swift production and equitable distribution of treatments and vaccines. It concludes by considering the possibilities that the legal and regulatory responses to this pandemic have illuminated for effectively tackling future global health crises.
Author: Belinda Bennett Publisher: Oxford University Press ISBN: 0192650491 Category : Law Languages : en Pages : 721
Book Description
COVID-19 is the most severe pandemic the world has experienced in a century. This book analyses major legal and regulatory responses internationally to COVID-19, and the impact the pandemic has had on human rights and freedoms, governance, the obligations of states and individuals, as well the role of the World Health Organization and other international bodies during this time. The authors examine notable legal challenges to public health measures enforced during the pandemic, such as lockdown orders, curfews, and vaccine mandates. Importantly, the book contextualizes the legal analysis by examining the broader social and economic dimensions of risks posed by the pandemic. The book considers how COVID-19 impacted the operation of the criminal justice system, civil litigation concerning negligently caused deaths and business losses arising from contractual breaches, consumer protection litigation, disciplinary regulation of health practitioners, coronial inquests and other investigations of unexpected deaths, and occupational health and safety issues. The book reflects on the role of the law in facilitating the remarkable scientific and epidemiological achievements during the pandemic, but also the challenges of ensuring the swift production and equitable distribution of treatments and vaccines. It concludes by considering the possibilities that the legal and regulatory responses to this pandemic have illuminated for effectively tackling future global health crises.
Author: Paul Diller Publisher: Aspen Publishing ISBN: Category : Law Languages : en Pages : 465
Book Description
This textbook surveys the major legal issues emanating from the policy responses to Covid-19 in the United States, with an emphasis on federalism, administrative law, and state and local government. The Covid-19 pandemic led to unprecedented policy responses from the various levels and organs of government in the United States, as well as from private parties. Business, school, and church closures, mask mandates, employer and university vaccine mandates, vaccine passports to visit movie theaters and restaurants — this panoply of responses changed the world many of us lived in and led to widespread and hotly contested litigation in America’s federal and state courts. In the first and only text of its kind, with carefully chosen case excerpts and summary information, The Law of Covid-19 highlights the key legal issues contested throughout the pandemic. Whether as a retrospective on what Covid wrought, a primer for future pandemics, or a supplement to a more general public health course, this text will help prepare you and your students for a world that will never be the same. Key Features: The Law of Covid-19 (“LC-19”) features carefully chosen and edited cases about public health authority at the federal and state levels. LC-19 focuses on the use of emergency authority by governors and mayors, including its impact on public employment and civil rights. LC-19 includes information on the federal and state health bureaucracies, including detailed recounting of the authorization and approval of the Covid-19 vaccines and boosters. Professors and students will benefit from: Organized discussion of the relevant sources of emergency and administrative authority at the federal and state levels. Thought-provoking questions and case notes that situate the relevant legal issues within the larger social and political context. A willingness to consider multiple perspectives, including those questioning whether the policy and legal response to Covid-19 may have been too draconian.
Author: Y. Tony Yang Publisher: Springer Nature ISBN: 3031369890 Category : Law Languages : en Pages : 230
Book Description
Vaccine Law and Policy is the first book on vaccine law and policy written specifically for the general public or an educated lay audience without legal background. It offers comprehensive but accessible coverage of key aspects of vaccine law and policy, from product development and intellectual property protections, to regulation, public mandates, and vaccine injury claims. The COVID-19 pandemic sparked a growing interest in learning more about vaccine law and policy, as vaccine development, access, safety and requirements became relevant to hundreds of millions of people worldwide. This book covers United States law in most detail, but the developments and trends described have parallels in many countries, and the United States model and its actions influence others. Some of the most widely used vaccines against COVID-19 - mRNA vaccines – were developed in the United States, and choices made in the United States impact other countries. United States law currently has so much to say about vaccines. From the federal mandate President Biden enacted requiring federal employees to be vaccinated against COVID-19, to the growing number of private employers requiring vaccines to return to work, vaccine law has become a prevalent topic in everyday life. But there is little writing about the legal aspects of vaccines directed at the general public or an educated lay audience without a legal background. Vaccine Law and Policy will not only be invaluable to professionals implementing vaccine law and policy, but also to regulators, public health officials, and scientific researchers. Vaccine Law and Policy covers the wide range of laws and policies that impact the field. These include, among others, regulatory oversight by the FDA, one of the most influential bodies in drug and vaccines regulation worldwide, enforcement, and regulation of the research and development of vaccines; vaccine mandates for children and in the workplace, and medical, religious, and philosophical exemptions to them; patent law and other intellectual property protections such as trademark, trade secret, unfair competition, and copyright law; compensation for vaccine injuries under the National Vaccine Injury Compensation Program (NVICP) and other avenues of liability; safety monitoring; access to vaccines, their promotion, and issues related to funding and costs. The book will also discuss issues related to anti-vaccine movements and vaccine advocacy.
Author: Nadia Mansour Publisher: Springer Nature ISBN: 3030894169 Category : Business & Economics Languages : en Pages : 231
Book Description
This book analyzes the impact of Covid-19 in different areas such as corporate social responsibility and legislation in SMEs, insolvency law, behavioral finance, government interventions in markets, financial disclosure, the emergence of unregulated financial sectors, the increase of coronavirus-related crimes, and the development of banking regulations in the Covid-19 pandemic, among others. The coronavirus epidemic, which has spread throughout the world, has highlighted the inadequacies of the health and social systems of all states, even the most advanced. The health emergency has required extraordinary measures, especially at the level of laws that are essential for the preservation of lives, health, and livelihoods. The priority for governments and even the international community was, from the outset, to prevent infections and care for those affected. Such a strategy required an unusual increase in health spending, even though it exceeded the State's financial capacity and lacked fiscal space. In addition to this challenge, which has not yet been overcome, there is another, that of redressing the consequences of the measures taken (general containment). It should be pointed out that during health crises, the state may have to review the requirement for transparency because of the emergency, but not free itself from it. The urgency could never be an alibi for a violation of citizens' rights and freedoms. With urgency, financial management systems must be flexible and responsive to all occurrences, while ensuring optimal use of resources and minimizing the risks of fraud and corruption.
Author: Publisher: Greenhaven Publishing LLC ISBN: 1534507302 Category : Young Adult Nonfiction Languages : en Pages : 130
Book Description
From the Black Death of the fourteenth century to more recent Ebola and SARS and the ongoing HIV/AIDS crisis, pandemics and disease outbreaks have devastated societies, wiped out significant portions of populations, and necessitated political, social, and scientific changes to address these public health catastrophes. When the COVID-19 virus effectively brought the world to its knees in 2020, it became clear that whatever scientists and policymakers had learned from historical pandemics wasn’t enough. Journalists, politicians, medical professionals, and other experts from a range of fields weigh in on how pandemics happen and evaluate the potential means of controlling them.
Author: Joseph R. Biden, Jr. Publisher: Simon and Schuster ISBN: 1510767614 Category : Political Science Languages : en Pages : 329
Book Description
The ultimate guide for anyone wondering how President Joe Biden will respond to the COVID-19 pandemic—all his plans, goals, and executive orders in response to the coronavirus crisis. Shortly after being inaugurated as the 46th President of the United States, Joe Biden and his administration released this 200 page guide detailing his plans to respond to the coronavirus pandemic. The National Strategy for the COVID-19 Response and Pandemic Preparedness breaks down seven crucial goals of President Joe Biden's administration with regards to the coronavirus pandemic: 1. Restore trust with the American people. 2. Mount a safe, effective, and comprehensive vaccination campaign. 3. Mitigate spread through expanding masking, testing, data, treatments, health care workforce, and clear public health standards. 4. Immediately expand emergency relief and exercise the Defense Production Act. 5. Safely reopen schools, businesses, and travel while protecting workers. 6. Protect those most at risk and advance equity, including across racial, ethnic and rural/urban lines. 7. Restore U.S. leadership globally and build better preparedness for future threats. Each of these goals are explained and detailed in the book, with evidence about the current circumstances and how we got here, as well as plans and concrete steps to achieve each goal. Also included is the full text of the many Executive Orders that will be issued by President Biden to achieve each of these goals. The National Strategy for the COVID-19 Response and Pandemic Preparedness is required reading for anyone interested in or concerned about the COVID-19 pandemic and its effects on American society.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 030968224X Category : Medical Languages : en Pages : 273
Book Description
In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.
Author: Susan Onel
Author: Susan Onel
Author: Belinda Bennett
Author: Belinda Bennett
Author: Paul Diller
Author: Y. Tony Yang
Author: Nadia Mansour
Author: 
Author: Joseph R. Biden, Jr.
Author: United States. Bureau of Employment Security
Author: National Academies of Sciences, Engineering, and Medicine